The European Medicines Agency (EMA) has requested all marketing authorisation holders (MAH) of medicines containing liposomal drug delivery systems to submit to EU regulators a variation to change the names of these medicines as soon as possible before the end of September 2019.
This recommendation aims to make a clearer distinction between
liposomal and non-liposomal formulations of the same active substance to avoid medication errors. Since the two formulations may have different biodistribution and release properties, medication errors can pose serious risks to the health of patients.
So far, there was no agreed approach to the naming of medicines containing liposomal or pegylated liposomal formulations.
The recommendation is made to enable healthcare professionals and patients to better distinguish them from conventional non-liposomal medicines. This is a particular concern when electronic prescribing and dispensing tools are used, as in the absence of a more descriptive term for the liposomal medicines, they can be mixed up with non-liposomal medicines, EMA said in a statement.
Following a number of reports of serious medication errors, some leading to death, and after consultation with EMA’s safety committee (PRAC), the CHMP and CMDh agreed on the following actions to reduce the risk of a mix-up between these medicines: In section 1 of the summary of product characteristics (SmPC), the qualifier ‘liposomal’ or ‘pegylated liposomal’ should be added after the invented name and before the strength.
This is in line with the standard practice for qualifiers. In those cases where medicine is approved with an ‘international non-proprietary name (INN)+company or trademark’ name, the qualifier ‘liposomal’ or ‘pegylated liposomal’ will be placed between the INN and the company name or trademark in section 1 of the SmPC. The currently existing EDQM standard term ‘dispersion’, which includes liposomes in its definition, should be used consistently throughout the product information.
Marketing authorisation holders of medicines with liposomal and pegylated liposomal delivery systems are requested to submit an A.2.a variation before the end of September 2019 to update their product name in line with the CHMP/CMDh recommendation.